510(k) · Cleared
ClearedBlood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Jamr Technology Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 25, 2020 as substantially equivalent to K190507 (Health & Life Co., Ltd., 2019) after a 122-day review. Its family tree reaches back 11 generations to 1985.
- Decided
- Jun 25, 2020
- Review
- 122 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K850316 (1985). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 7 generations between
- 3 generations backK142968 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2014
- 2 generations backK160145 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- 1 generation backK190507 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2019
- This deviceK200437 Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd. · 2020
Show all 11 generations
- Root · 11 generations backK850316 Unisonic Electronic Digital BP Monitor Ebm-2050Nihon Seimitsu Sokki Co., Ltd. · 1985
- 10 generations backK993890 Digital Blood Pressure Monitor, Model DS-181Nihon Seimitsu Sokki Co., Ltd. · 1999
- 9 generations backK050697 Model DS-1901 Digital Blood Pressure MonitorNihon Seimitsu Sokki Co., Ltd. · 2005
- 8 generations backK071384 Modification to: Digital Blood Pressure Monitor, Model 1901Nihon Seimitsu Sokki Co., Ltd. · 2007
- 7 generations backK080177 Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PVNihon Seimitsu Sokki Co., Ltd. · 2008
- 6 generations backK092161 Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BFHealth & Life Co., Ltd. · 2009
- 5 generations backK093831 Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RTHealth & Life Co., Ltd. · 2010
- 4 generations backK131121 Full Automatic (Nibp) Blood Pressure MonitorHealth & Life Co., Ltd. · 2013
- 3 generations backK142968 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2014
- 2 generations backK160145 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2016
- 1 generation backK190507 Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. · 2019
- This deviceK200437 Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K850316 | Unisonic Electronic Digital BP Monitor Ebm-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985 | — |
| −10 | K993890 | Digital Blood Pressure Monitor, Model DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999 | — |
| −9 | K050697 | Model DS-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | 2005 | — |
| −8 | K071384 | Modification to: Digital Blood Pressure Monitor, Model 1901 | Nihon Seimitsu Sokki Co., Ltd. | 2007 | — |
| −7 | K080177 | Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV | Nihon Seimitsu Sokki Co., Ltd. | 2008 | — |
| −6 | K092161 | Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF | Health & Life Co., Ltd. | 2009 | — |
| −5 | K093831 | Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT | Health & Life Co., Ltd. | 2010 | — |
| −4 | K131121 | Full Automatic (Nibp) Blood Pressure Monitor | Health & Life Co., Ltd. | 2013 | — |
| −3 | K142968 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2014 | — |
| −2 | K160145 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2016 | — |
| −1 | K190507 | Full Automatic (NIBP) Blood Pressure Monitor | Health & Life Co., Ltd. | 2019 | — |
| 0 (this device) | K200437 | Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190507 | Full Automatic (NIBP) Blood Pressure MonitorSummary page 4…n Sponsor: Health & Life Co., Ltd. Device: Full Automatic (NIBP) Blood Pressure Monitor HL858CL 510(K) Number: K190507 Page 1 of 9 K200437… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 1 other device also cites its predicate K190507.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by
using the oscillometric method during inflation. Measurement position is at human being’s upper arm. The intended use of
this over-the-counter device is for adults at medical facilities or at home. The intended upper arm circumference is
22-40cm (8.7” — 15.7”). Not suitable for neonatal and infants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200437 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200437: Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200437
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026